FDA APPROVALS

The U.S. Food and Drug Administration approved gilteritinib (Xospata; Astellas) for treatment of adult patients who have relapsed or refractory acut myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA approved test. Read full press release.

The U.S. Food and Drug Administration approved atezolizumab (Tecentriq; Genentech) in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. Read full press release.

The U.S. Food and Drug Administration approved romiplostim (Nplate; Amgen) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Read full press release. 

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda; Merck) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Read full press release.

The U.S. Food and Drug Administration approved olaparib (Lynparza; AstraZeneca Pharmaceuticals) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Read full press release.

The U.S. Food and Drug Administration approved ravulizumab-owvz (Ultomiris; Alexion Pharmaceuticals, Inc.) for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Read full press release.